DATE: Saturday, July 12, 1997               TAG: 9707120308

SECTION: LOCAL                   PAGE: B1   EDITION: FINAL 

SOURCE: BY PAT DOOLEY, STAFF WRITER 

                                            LENGTH:   87 lines

FDA PREPARES RULES ON HERBAL DIET AID INGREDIENT

On a recent trip to the mall, Teresa Brooks spotted a nutrition-store display of ``Herbal Phen-Fen'' and stopped to check it out.

A friend of Brooks' had been using the prescription weight-loss drugs dubbed fen-phen. This week, the Food and Drug Administration implicated the combination of the drugs - fenfluramine and phentermine - in heart-valve disease in 24 previously healthy women who had used the diet aids for about a year. It warned consumers to be cautious about using the drugs, especially for small weight losses.

Brooks, of Virginia Beach, figured her friend might be better off taking an herbal version. She decided to read the label to see what the product contained. But she didn't get a chance - the store already had sold out of its supply.

If she had been able to read the packaging, Brooks would have learned that two tablets of Herbal Phen-Fen contain ``Mahuang extract (8% alkaloids) (Ephedra sinica) (herb),'' among other natural, plant-derived ingredients.

What readers might not know is that Ma huang, or Ephedra, also has been associated with more than 800 illnesses and 38 deaths in the United States since 1994, and that the FDA has proposed new guidelines for products containing the ancient Chinese herb.

The proposal, if approved, would limit the amount of ephedrine alkaloids in products to 8 milligrams a serving, or 24 milligrams a day, said Arthur Whitmore, an FDA spokesman. Currently, there is no ceiling, and it's difficult to know how much Ephedra a product contains.

The new rules also would require labels telling consumers not to use the product for more than seven days. And the products could not be marketed specifically for weight loss, a practice permitted now, Whitmore said.

Ephedrine alkaloids are derived from one of several species of herbs of the genus Ephedra, sometimes called Ma huang or epitonin.

Pharmaceutical, or manufactured, Ephedra is found in some over-the-counter drugs, such as allergy-relief and asthma medications.

Because it is an amphetamine-like stimulant of the heart and nervous system, people with certain medical conditions - such as heart disease, diabetes and high blood pressure - should not use products containing it, Whitmore said.

``Natural is not automatically safe,'' he said, ``or safer than fen-phen.''

Nevertheless, consumers are scooping up natural remedies, including diet aids.

Herbal Phen-Fen, for example, is one of the most popular products at GNC outlets across the country, said Gregory Miller, a spokesman for the nutrition and health store chain.

Shoppers like Brooks look for products labeled ``herbal'' or ``natural.''

``I like knowing they're plant-derived,'' Brooks said.

At the Heritage Store in Virginia Beach, herbal buyer Tina Griffin said few items in stock contain Ephedra. Shoppers there must be 21 to purchase items that do. The store even posts a warning to buyers who might not know Ephedra is a stimulant.

``Just because it's herbal doesn't mean it's safe for everyone,'' she said.

Ephedra also is used in some athletic-performance enhancers and energy boosters.

Some Ephedra products contain additional stimulants, such as caffeine or cola nut, adding to the potential danger, Whitmore said. Under the FDA proposal, such combinations would no longer be allowed.

The hundreds of Ephedra-related problems reported to the agency over the last three years have included high blood pressure, headaches, dizziness, heart attacks, seizures and strokes.

Most of the problems have occurred in young or middle-aged women using weight-loss products, he said.

The FDA doesn't plan to ban Ephedra, Whitmore said. He acknowledged that in some cases it may help weight loss by boosting heart rate and blood pressure, or metabolism.

Moira Saucer, communications manager for the Council for Responsible Nutrition, a trade group, said many manufacturers support a dosage limit but do not agree with the seven-day lid on use.

Ephedra is safe when used correctly, they say.

Dr. Joseph J. DiBartolomeo is vice president for scientific affairs for Nutri-System, which distributes Herbal Phen-Fen to its 500 weight-loss centers and to various health stores.

He said many problems reported to the FDA occurred in products containing other stimulants. Herbal Phen-Fen, on the market for about three months, does not.

Patients have sampled Herbal Phen-Fen with good results, DiBartolomeo said, and a clinical study is being conducted at St. Luke's-Roosevelt Hospital Center in New York. ILLUSTRATION: IAN MARTIN/The Virginian-Pilot

The government has proposed new guidelines for products containing

Ephedra, such as Herbal Phen-Fen, warning people to stop taking the

product after seven days.

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